Calibration in the FDA Regulated Industry
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Who Should Attend
This overview course is intended for individuals in all
industries, but specifically individuals in FDA regulated
industries, who are responsible for establishing, maintaining
and operating a calibration program and audit of calibration
activities, including:
• Quality Assurance
• Quality Control
• Quality Engineering
• Technical Support
• Research and Development
• Facilities and Equipment Maintenance
Description
The regulations covering manufacture and control of drug
products and medical devices require that firms have a
program for the calibration of test and measurement
equipment. A requirement for calibration is also defined in ISO
9000 and a Quality System for a calibration laboratory is
described in ISO 17025. Calibration is a good business and
science practice followed in all industries that require
measurements for process monitoring and control. The
program must include the elements of: calibration intervals,
scheduling, specific calibration procedures, limits of accuracy
and precision and remedial action in the event that the
instrument does not meet established requirements.
This course addresses the regulatory and business
requirements for calibration as an element of a Quality System
and how these requirements support the increasing application
of process monitoring and sophisticated laboratory
instrumentation, along with the maturing discipline of
calibration in the regulated industries. It includes a discussion
of a compliant calibration program and concludes with a
discussion of a model calibration procedure.